An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
1 other identifier
interventional
370
1 country
18
Brief Summary
The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 15, 2003
CompletedFirst Posted
Study publicly available on registry
May 16, 2003
CompletedAugust 4, 2006
August 1, 2006
May 15, 2003
August 2, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.
Secondary Outcomes (2)
Change from baseline to the final evaluation for the Manic Syndrome Scale (MSS), Behavior and Ideation Scale (BIS),
BPRS (and published subscales), Global Assessment Scale (GAS), the Nursing Observation Scale for Inpatient Evaluation (NOSIE), and Burden Questionnaire, as well as the percentage of subjects with at least 50% improvement on the MRS.
Interventions
Eligibility Criteria
You may qualify if:
- Current primary diagnosis of bipolar I disorder, mania or mixed type
- Acute exacerbation of mania associated with bipolar disorder as defined by Mania Rating Scale score \>= 18
- Hospitalized no more than 7 days at time of Screening or in process of being admitted
- History of at least one prior manic or mixed episode within past 3 years, exclusive of the current episode. Prior manic or mixed episode must be separated from current episode by at least 2 months of sustained improvement
You may not qualify if:
- History of schizophrenia or schizoaffective disorder
- Axis I (e.g., anxiety disorder), or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
- Current manic or mixed episode is drug-induced or secondary to a medical disorder (e.g., AIDS, corticosteroids)
- Current manic or mixed episode is believed to be caused by antidepressant use (i.e., antidepressant-induced mania)
- Had first manic episode after age 60
- Has ever taken clozapine
- Has received depot neuroleptic medication within one inter-injection interval of first dose of study drug
- Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
- History of active alcohol or substance dependence within past 3 months.
- History of failed treatment on adequate valproate therapy for bipolar disorder
- Has taken Depakote (DR or ER) regularly over the last 30 days
- Has serious violent, homicidal, or suicidal ideation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (18)
Comprehensive Neuroscience of SCA
Cerritos, California, 90703, United States
AVI Clinical Research
Torrance, California, 90505, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Mark Lerman, MD
Hoffman Estates, Illinois, 60194, United States
University of Louisville Bipolar Research Program
Louisville, Kentucky, 40202, United States
Brentwood Research Inst.
Shreveport, Louisiana, 71101, United States
Centers for Behavioral Health, LLC
Rockville, Maryland, 20850, United States
McLean Hospital
Belmont, Massachusetts, 02478, United States
Pioneer Research
Baltimore, Michigan, 48047, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Steven A. Glass, MD
Clementon, New Jersey, 08021, United States
The Holliswood Hospital
Holliswood, New York, 11423, United States
NYU School of Medicine - Bellevue
New York, New York, 10016, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
UT Mental Sciences Institute
Houston, Texas, 77030, United States
San Antonio State Hospital
San Antonio, Texas, 78223, United States
CNS of Northern Virginia
Falls Church, Virginia, 22041, United States
VAMC
Milwaukee, Wisconsin, 53295, United States
Related Publications (2)
Hirschfeld RM, Bowden CL, Vigna NV, Wozniak P, Collins M. A randomized, placebo-controlled, multicenter study of divalproex sodium extended-release in the acute treatment of mania. J Clin Psychiatry. 2010 Apr;71(4):426-32. doi: 10.4088/JCP.08m04960yel. Epub 2010 Mar 9.
PMID: 20361904DERIVEDBowden CL, Swann AC, Calabrese JR, Rubenfaer LM, Wozniak PJ, Collins MA, Abi-Saab W, Saltarelli M; Depakote ER Mania Study Group. A randomized, placebo-controlled, multicenter study of divalproex sodium extended release in the treatment of acute mania. J Clin Psychiatry. 2006 Oct;67(10):1501-10. doi: 10.4088/jcp.v67n1003.
PMID: 17107240DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Medical Information - Abbott
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 15, 2003
First Posted
May 16, 2003
Study Start
January 1, 2003
Last Updated
August 4, 2006
Record last verified: 2006-08